Clinical Trial: IVF Outcomes After Varicocele Repair

U.S., March 28 -- ClinicalTrials.gov registry received information related to the study (NCT03090438) titled 'IVF Outcomes After Varicocele Repair' on March 20.
Brief Summary: Infertility has been estimated to affect from 6-18% of couples trying to conceive. In 20-30% of cases, the problem is with the male. Varicocele is a common cause of male factor infertility (MFI) being responsible for 30-35 % of primary and 69-81 % of secondary MFI. Varicocele repair has been shown to improve sperm parameters and increase natural pregnancy rates and the results of assisted reproductive techniques (ART).
There are two possible treatment pathways for varicocele associated male factor infertility. 1) standard IVF/ICSI 2) varicocele repair followed by IVF/ICSI if there is no spontaneous pregnancy. There is however no consensus as to which pathway is preferable and no randomized comparative studies have been carried out.
IVF/ICSI is a standard treatment for infertility but frequently requires repeated treatments to achieve a live birth. The purpose of this study is to determine if the improved sperm parameters caused by prior treatment of the varicocele will result in improvements both in overall pregnancy/birth rates and in IVF/ICSI results.
Study Start Date:
Study Type: Interventional
Condition: Infertility, Male
Varicocele
In Vitro Fertilization
Intervention: Procedure: Varicocele embolization
Ultrasound guided right internal jugular vein access with placement of a vascular sheath. Fluoroscopically guided selective catheterization of the left and right (if bilateral) spermatic veins to the level of the inguinal ligament. Occlusion of the spermatic vein(s) by embolization coils and a sclerosing agent (sodium tetradecyl sulphate 3%).
Other Names:
Varicocele repair
Varicocele occlusion
Recruitment Status: Not yet recruiting
Sponsor: Shaare Zedek Medical Center
Information provided by (Responsible Party): Shaare Zedek Medical Center